Medical and Serological Follow-up of the Staff of the Paris Saint-Joseph Hospital Group Infected With Severe Acute Respiratory Syndrome Coronavirus 2.

NCT04488484 | Completed

• 1 other identifier: PERSO-COVID
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Coronavirus SARS CoV-2 (COVID-19) pandemic is causing a major global health crisis that is disrupting our hospital organizations and creating potential infectious risks for hospital staff on the front line when it comes to the support of infected people. In this context, the Paris Saint-Joseph Hospital Group (GhPSJ) very early on wanted to implement an institutional approach aimed, on the one hand, at enabling each of its employees at its two sites (Hôpital Paris Saint-Joseph (HPSJ), Paris 14ème and Hôpital Marie Lannelongue (HML), Le Plessis Robinson, 92) to access their serological status with regard to SARS-CoV-2 and, on the other hand, to identify the risk factors for contracting COVID-19. This collective approach consisted of an evaluation of its professional practices aimed at assessing the protective measures put in place to protect hospital personnel and identifying sources of potential improvement in the management of the infectious risk required to put in place in case of upcoming COVID-19 cases or any other epidemics in the future.

Conditions

COVID-19

Keywords

COVID-19; coronavirus; SARS-CoV2

Outcome Measures

Primary Outcomes (2)

• Immune Response description

  The research will describe and distinguish the type of immune response observed both on the basis of the titers of antibodies (IgG and IgM) produced.

  1 month

• Evolution of the SARS-CoV2 overtime

  the serology test will observe the evolution of the COVID-19 over time, its impact on the staff infected and the memory carried by the associated cellular reaction.

  1 month (after the 1st serology test results)

Secondary Outcomes (2)

• Clinical and Immunological Analysis

  2 months

• Comparison of the occurrence of clinical events with other immunological data

  2 months

Study Arms (1)

Arm

OTHER

Serology test results The Paris Saint- Joseph Hospital Group staff was submitted to a 2 times serology test: the 1st took place between April, 20th to May, 12th and the second, between May, 26th to June, 12th. The employees presenting positive antibodies titers to SARS-CoV-2 will be contacted and asked for a 12 month follow-up study organized by the Occupational Health Team and the team of COVID-19 Serology referents appointed to carry out and coordinate the procedure. Each enrolled member will receive a letter with containing an information letter describing the study with a written consent form and a questionnaire enabling the data to be collected individually on the COVID-19 infection.

Other: Serology test follow-up

Interventions

Serology test follow-up OTHER

The enrolled participants will be invited to visit ESS. They will then meet the occupational physician, who wil obtain their free, informed and written consent. The information and consent will be recorded in the personal medical follow-up file.The staff will then complete the self-questionnaire and the ESS physician will provide a prescription for the blood samples to be taken. In case of positive answers to one or more of the questions in this self-questionnaire, the enrolled participant will be contacted in order to schedule another post-COVID-19 consultation with additional examinations if needed (new COVID PCR, scanner, etc.).

Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• employee aged over 18 years
• employee who participated to the serology tests
• employee who was tested positively to the Covid-19 serology test
• French speaking employee
• employee affiliated to a French social security or any other health insurance system.
• employee who is able to give its free and written consent.

You may not qualify if:

• employee under guardianship or curatorship
• employee deprived of liberty
• employee under the protection of justice.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (6)

• Janice Oh HL, Ken-En Gan S, Bertoletti A, Tan YJ. Understanding the T cell immune response in SARS coronavirus infection. Emerg Microbes Infect. 2012 Sep;1(9):e23. doi: 10.1038/emi.2012.26. Epub 2012 Sep 5.

  PMID: 26038429 BACKGROUND

• Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7.

  PMID: 31981224 BACKGROUND

• Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.

  PMID: 32356910 BACKGROUND

• Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID-19 and potential vaccines: Lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol. 2020 Mar;38(1):1-9. doi: 10.12932/AP-200220-0772.

  PMID: 32105090 BACKGROUND

• Salje H, Tran Kiem C, Lefrancq N, Courtejoie N, Bosetti P, Paireau J, Andronico A, Hoze N, Richet J, Dubost CL, Le Strat Y, Lessler J, Levy-Bruhl D, Fontanet A, Opatowski L, Boelle PY, Cauchemez S. Estimating the burden of SARS-CoV-2 in France. Science. 2020 Jul 10;369(6500):208-211. doi: 10.1126/science.abc3517. Epub 2020 May 13.

  PMID: 32404476 BACKGROUND

• Pilmis B, Elkaibi I, Pean de Ponfilly G, Daikha H, Bouzid A, Guihot A, Castreau N, Pradere P, Ketatni H, Mondragon A, Hayem G, Le Pavec J, Laplanche S, Le Monnier A. Evolution of anti-SARS-CoV-2 immune response in a cohort of French healthcare workers followed for 7 months. Infect Dis Now. 2022 Mar;52(2):68-74. doi: 10.1016/j.idnow.2022.01.004. Epub 2022 Jan 19.

  PMID: 35063702 RESULT

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The research is a prospective, follow-up cohort, non-randomized and interventional study that aims at following patients who presented a positive serology for the COVID-19

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 23, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)